MAUDE Adverse Event Report: ST. JUDE MEDICAL ENGAGE¿; INTRODUCER, CATHETER

Model Number	C408509
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
While obtaining access for an ablation, a venous sheath was attempted to be flushed by physician and physician was unable to do so.It was then determined that the sheath was fractured and approximately 5 cm of the 11 cm sheath was left in the patient.Multiple physicians were called to assist with removal including vascular surgery.After cutdown, the fractured sheath was removed.The patient remained stable, but the eps study and svt ablation were aborted.The patient was discharged home the following day with no reported complications post op.Awaiting response from manufacturer, the device will be returned for failure analysis.

• Brand Name: ENGAGE¿
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7669394
• Report Number: 7669394
• Device Sequence Number: 805149
• Product Code: DYB
• UDI-Device Identifier: 05414734053037
• UDI-Public: (01)05414734053037
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2018
• Report Date (Section F): 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: C408509
• Device Catalogue Number: C408509
• Device Lot Number: 6335418
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 112
• Date Report Sent to FDA: 06/20/2018